federal_register: 2014-29034

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2014-29034 Determination That PFIZERPEN (Penicillin G Potassium) Injection, 1 Million Units/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice The Food and Drug Administration (FDA) has determined that PFIZERPEN (penicillin G potassium) Injection, 1 million units/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for penicillin G potassium injection, 1 million units/vial, if all other legal and regulatory requirements are met. 2014-12-11 2014 12 https://www.federalregister.gov/documents/2014/12/11/2014-29034/determination-that-pfizerpen-penicillin-g-potassium-injection-1-million-unitsvial-was-not-withdrawn https://www.govinfo.gov/content/pkg/FR-2014-12-11/pdf/2014-29034.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) has determined that PFIZERPEN (penicillin G potassium) Injection, 1 million units/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated...

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